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Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile

StatusCompleted
PhaseNot applicable
Started2022-07-25
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
notable
Trial completed
Final enrollment: 261 participants (planned 300)
Study completion confirmed: November 2025 (last estimated August 2026)
2026-03-02
minor
Study Status, Oversight v6
Primary completion dateestimated 2025-08→confirmed 2025-06-01
2025-07-31
minor
Study Status, Oversight v5
Re-verified, no change to tracked fields
2024-07-19
minor
Study Status, Study Design v4
Enrollment target150→300
2022-09-23
minor
Study Status, Sponsor/Collaborators, Arms and Interventions v3
Collaborators2 to 4 entries
Massachusetts Host-Microbiome Center Hatch Family Foundation
Show 2 earlier versions
2022-08-29
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-06→2025-08
Completion date2026-06→2026-08
Start dateestimated 2022-06→confirmed 2022-07-25
Study sites0→1
2022-06-02
minor
Study Status, Conditions v1
Re-verified, no change to tracked fields
2022-05-20
minor
Original filing
Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.
Trial Details
NCT Number NCT05389904
Lead Sponsor Brigham and Women's Hospital
Collaborators: Harvard Pilgrim Health Care Institute, Centers for Disease Control and Prevention, Massachusetts Host-Microbiome Center, Hatch Family Foundation
Conditions C. Difficile
Enrollment 261 participants
Start Date 2022-07-25
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-11-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-30